Mindray V60 User manual

V60 Anesthetic Vaporizer
Operator’s Manual

Ⅰ
© 2009-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is September, 2016.

II
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray)
owns the intellectual property rights to this Mindray product and this manual. This manual may refer to
information protected by copyright or patents and does not convey any license under the patent rights
or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the
information in this manual in any manner whatsoever without the written permission of Mindray is
strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any
other derivative work of this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.
, and are the trademarks, registered or otherwise, of Mindray in China
and other countries.
All other trademarks that appear in this manual are used only for editorial purposes without the
intention of improperly using them. They are the property of their respective owners.

III
Manufacturer's Responsibility
Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable for errors
contained herein or for incidental or consequential damages in connection with the furnishing,
performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product, only if:
all installation operations, expansions, changes, modifications and repairs of this product are
conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national and local
requirements;and
the product is used in accordance with the instructions for use.
WARNING
zThis Anesthetic Vaporizer must be operated by skilled/trained clinical
professionals.
zIt is important for the hospital or organization that uses this equipment perform a
reasonable service/maintenance plan. Neglecting this may result in machine
breakdown or personal injury.

IV
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other
charges or liability for direct, indirect or consequential damages or delay resulting from the improper
use or application of the product or the use of parts or accessories not approved by Mindray or repairs
by people other than Mindray authorized personnel.
This warranty shall not extend to:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by major forces such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified
orunauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
Customer Service Department
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building,Keji 12th Road South,High-tech industrial
park,Nanshan,Shenzhen 518057,P.R.China
Website: www.mindray.com
E-mail Address: [email protected]
Tel: [phone]
Fax: [phone]
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, 20537 Hamburg, GERMANY
Tel: [phone]
Fax: [phone]

1
Table of Contents
1 Safety......................................................................................................................................... 1-1
1.1 Safety Information .................................................................................................................. 1-1
1.1.1 Warnings............................................................................................................. 1-2
1.1.2 Cautions ............................................................................................................. 1-3
1.1.3 Notes .................................................................................................................. 1-3
1.2 Anesthetic Vaporizer Symbols ................................................................................................ 1-4
2 The Basics ................................................................................................................................. 2-1
2.1 Product Description................................................................................................................. 2-1
2.2 Intended Use ........................................................................................................................... 2-2
2.3 Anesthetic Vaporizer Appearance............................................................................................ 2-2
2.3.1 Front View.......................................................................................................... 2-2
2.3.2 Rear View........................................................................................................... 2-3
2.4 Configuration Differences....................................................................................................... 2-4
3 Method of Operation ............................................................................................................... 3-1
3.1 Control Dial............................................................................................................................. 3-1
3.2 Connecting and Interlock System ........................................................................................... 3-1
3.2.1 Plug-in Adapter/Plug-in Connector.................................................................... 3-2
3.2.2 Interlock Device................................................................................................. 3-4
3.3 Filling System ......................................................................................................................... 3-5
4 Filling and Draining................................................................................................................. 4-1
4.1 Checks before Filling .............................................................................................................. 4-1
4.2 Filling the Vaporizer................................................................................................................ 4-1
4.2.1 Pour Fill System................................................................................................. 4-3
4.2.2 Key Filler System............................................................................................... 4-6
4.2.3 Quik-Fil System ................................................................................................4-11
4.3 Draining the Vaporizer .......................................................................................................... 4-13
4.3.1 Pour Fill System............................................................................................... 4-13
4.3.2 Key Filler System............................................................................................. 4-16
4.3.3 Quik-Fil System ............................................................................................... 4-19
4.4 Blowing off the Vaporizer ..................................................................................................... 4-20
5 Checks before Use.................................................................................................................... 5-1
5.1 Checklist—checks before each use......................................................................................... 5-1
5.2 Setting Checks......................................................................................................................... 5-2
6 Basic Operations ...................................................................................................................... 6-1
6.1 Connecting the Vaporizer........................................................................................................ 6-1
6.2 Adjusting the Concentration of Anesthetic Agent ................................................................... 6-4

2
6.3 Switching off the Vaporizer..................................................................................................... 6-6
6.4 Disconnecting the Vaporizer ................................................................................................... 6-6
6.5 Moving when Filled ................................................................................................................ 6-7
7 Cleaning and Disinfecting........................................................................................................ 7-1
7.1 Cleaning .................................................................................................................................. 7-1
7.2 Disinfecting............................................................................................................................. 7-2
8 User Maintenance..................................................................................................................... 8-1
8.1 Repair Policy........................................................................................................................... 8-1
8.2 Maintenance Schedule ............................................................................................................ 8-2
8.3 Checking the Concentration.................................................................................................... 8-2
8.4 Checking the Filling System ................................................................................................... 8-4
8.5 Checking the Plug-in Adapter ................................................................................................. 8-4
9 Troubleshooting........................................................................................................................ 9-1
9.1 Operation Related Faults and Remedies ................................................................................. 9-1
9.2 Filling and Draining Related Faults and Remedies................................................................. 9-3
9.3 Plug-in Adapter Related Faults and Remedies........................................................................ 9-3
10 Storage and Transport......................................................................................................... 10-1
10.1 Storage ................................................................................................................................ 10-1
10.2 Transport ............................................................................................................................. 10-2
11 Theory of Operation..............................................................................................................11-1
11.1 Operating Principle ..............................................................................................................11-1
11.2 Calibration............................................................................................................................11-3
11.3 Influence of Temperature .....................................................................................................11-3
11.4 Influence of Flow .................................................................................................................11-6
11.5 Influence of Gas Composition..............................................................................................11-8
11.6 Influence of Atmospheric Pressure.......................................................................................11-9
11.7 Influence of Fluctuations in Pressure ...................................................................................11-9
11.8 Influence of Running Time ................................................................................................11-10
A Product Specifications............................................................................................................ A-1
A.1 Standards Compliance........................................................................................................... A-1
A.2 Physical Specifications.......................................................................................................... A-1
A.3 Operating Range.................................................................................................................... A-2
A.4 Performance Specifications................................................................................................... A-2
A.5 Product Configurations ......................................................................................................... A-3
A.6 Flow Range ........................................................................................................................... A-3
B Accessories List........................................................................................................................B-1

3
C Symbols and Terminology ..................................................................................................... C-1
C.1 Symbols..................................................................................................................................C-1
C.2 Terminology ...........................................................................................................................C-1

4
FOR YOUR NOTES

1-1
1 Safety
1.1 Safety Information
WARNING
zIndicates a potential hazard or unsafe practice that, if not avoided, could result in
death or serious injury.
CAUTION
zIndicates a potential hazard or unsafe practice that, if not avoided, could result in
minor personal injury or product/property damage.
NOTE
zProvides application tips or other useful information to ensure that you get the most
from your product.

1-2
1.1.1 Warnings
WARNING
zDo not operate the Anesthetic Vaporizer before reading this manual.
zThe user of the Anesthetic Vaporizer must fully understand and strictly follow the
instructions for use.
zBefore putting the system into operation, the user must verify that the Anesthetic
Vaporizer is in correct working order and operating condition.
zDo not use the Anesthetic Vaporizer in the environment outside the specified
temperature and pressure ranges.
zTo avoid explosion hazard, do not use the Anesthetic Vaporizer in the presence of
flammable anesthetic agent, vapors or liquids.
zDispose of the package material, observing the applicable waste control regulations and
keep them out of children’s reach.
zTo avoid explosion hazard, use only specified non-combustible anesthetic agent in
compliance with the requirement of ISO80601-2-13.
zAny unauthorized organization or untrained person must not change or disassemble
the Anesthetic Vaporizer.
zThis Anesthetic Vaporizer may not be modified without the manufacturer’s
permission.
zThe medical device must be inspected and serviced regularly by service personnel.
zBefore use, check that the shipping package is intact.
zThe Anesthetic Vaporizer shall not be serviced or maintained while in use with a
patient.
zDo not use the Anesthetic Vaporizer when there is an anesthetic agent leak..
zThe vaporizer is designed for use only with the specific anesthetic agent named on the
filler block (and further indicated by labels of different colors). Do not use the
vaporizer if the vaporizer is filled with any agent other than the agent specified on the
front label.
zThis Anesthetic Vaporizer is not suitable for use in an MRI environment.

1-3
1.1.2 Cautions
CAUTION
zUse only accessories specified in this manual.
zAt the end of its service life, the Anesthetic Vaporizer, as well as its accessories, must be
disposed of in compliance with the guidelines regulating the disposal of such products.
zThe Anesthetic Vaporizer may become unstable if the unit is tilted beyond 10 degrees.
zAlways install or carry the Anesthetic Vaporizer properly to avoid damage caused by
drop, impact, strong vibration or other mechanical force. Do not carry by the control
dial or the handle for locking lever.
1.1.3 Notes
NOTE
zKeep this manual close to the Anesthetic Vaporizer so that it can be obtained
conveniently when needed.
zThis manual describes all features and options. Your Anesthetic Vaporizer may not
have all of them.
zThis product is latex free.

1-4
1.2 Anesthetic Vaporizer Symbols
Refer to instruction manual/booklet
Gas flow direction
Adjust concentration as the arrow shows
Press and lock as the arrow shows
Caution
MR Unsafe – do not subject to magnatuc resonance imaging (MRI)
EAC
Unified circulation mark indicates that products marked them passed
all specified in the technical regulations of the Customs Union of the
procedure for the assessment (confirmation) of conformity and
complies with the requirements applicable to all the products technical
regulations of the Customs Union.

2-1
2 The Basics
2.1 Product Description
This vaporizer is an unheated, calibrated anaesthetic vaporizer outside the circuit. It is used jointly with
the fresh gas delivery system and provides accurate concentration of anaesthetic agent through the
control dial.
Each vaporizer is calibrated for a specified anesthetic agent and is only suitable for that anesthetic
agent. The specific agent that the vaporizer must be used with is marked in text and by specific color
on the vaporizer.
The vaporizer provides the function of temperature, air pressure and flow compensations. Therefore,
under the circumstances specified in this manual, the output concentration of the vaporizer is not
influenced by ambient conditions, such as temperature, gas flow and ventilation pressure.
The Anesthetic Vaporizer is not suitable for use with an anesthetic delivery system with vaporizer
placed inside the circuit system due to relatively high internal pneumatic resistance.
The vaporizer delivery system is in compliance with ISO80601-2-13.
The Key Filler system is in compliance with ISO5360.
Quik-Fil system complies with the performance data of ISO5360.
Mindray recommends that the output concentration is monitored through an anesthetic gas monitoring
device in compliance with ISO80601-2-55 to detect any hazardous output values.
Use an anesthetic gas scavenging system in compliance with ISO80601-2-13 to minimize atmospheric
pollution in the operating room.
WARNING
zDo not use the Anesthetic Vaporizer in mobile vehicles, aeroplanes, helicopters and
ships.

2-2
2.2 Intended Use
V60 anesthetic vaporizer is an unheated, calibrated anesthetic vaporizer used for evaporating liquid
anesthetic agents and delivering mixed gas of controlled concentration to an anesthetic delivery
system.
It is available in Isoflurane, Sevoflurane, Enflurane and Halothane variants.
WARNING
zThe Anesthetic Vaporizer is intended to be operated only by licensed clinicians and
qualified anesthesia personnel who have received adequate training in its use. Anyone
unauthorized or untrained must not perform any operation on the Anesthetic
Vaporizer.
zThis Anesthetic Vaporizer is not suitable for use in an MRI environment.
2.3 Anesthetic Vaporizer Appearance
2.3.1 Front View
1. “0” button
2. Control dial
3. Filling system
4. Color mark for anesthetic agent
5. Sight glass for filling level
6. Drainage knob

2-3
2.3.2 Rear View
1. Handle for locking lever
2. Interlock system
3. Locking pin

2-4
2.4 Configuration Differences
Model Anesthetic agent Filling system Accessory
Sevoflurane Key Filler
Vaporizer
Sevoflurane Key Filler system Sevoflurane Key Filler filling
adapter
Isoflurane Key Filler
Vaporizer Isoflurane Key Filler system Isoflurane Key Filler filling adapter
Sevoflurane Quik-Fil
Vaporizer Sevoflurane Quik-Fil system
Sevoflurane Quik-Fil filling adapter
Sevoflurane Quik-Fil drainage
funnel
Sevoflurane Pour Fill
Vaporizer Sevoflurane Pour Fill system /
Enflurane Key Filler
Vaporizer Enflurane Key Filler system /
Enflurane Pour Fill
Vaporizer Enflurane Pour Fill system Enflurane Key Filler filling adapter
Halothane Key Filler
Vaporizer
Halothane
Key Filler system /
Halothane Pour Fill
Vaporizer
Halothane
Pour Fill system Halothane Key Filler filling adapter
Sevoflurane Key Filler
Vaporizer
Sevoflurane
Key Filler system /

3-1
3 Method of Operation
3.1 Control Dial
The control dial is used to set the output concentration of the anesthetic agent. The control dial is
marked with output concentration of the anesthetic agent from the vaporizer. The graduation to which
the dial is turned indicates the output concentration.
The “0” button on the vaporizer has locking function. Press this button first before turning the control
dial.
If the vapour is stored in high temperature and then used, the concentration of the delivered anesthetic
agent may be high. To enable pressure equalization, always turn the control dial to 1% after connecting
the anesthetic workstation, and wait for at least 15 seconds.
3.2 Connecting and Interlock System
When the anesthetic delivery system is connected to multiple vaporizers, the interlock systems of the
vaporizers ensure that only one vaporizer can be switched on at any one time while the others are
switched off and blocked.
“0” button
control dial

3-2
3.2.1 Plug-in Adapter/Plug-in Connector
The vaporizer is applicable to anesthetic delivery systems with plug-in connectors with an Ohmeda
Selectatec® compatible manifold system.
The holes in the plug-in adapter on the vaporizer fit onto the pins on the plug-in connector on the
anesthetic delivery system.
Interlock device
Plug-in adapter and pin
Plug-in connector